Global Research Antibodies Market: Overview

The global research antibodies market is anticipated to rise at a notable pace over the forecast period. Antibodies display exceptional physiological properties that make them sought-after for cell research.

Antibodies display other properties too. As they have the ability to attach to specific molecules, this enables specific molecules to be isolated for research. Hence, this makes for a key factor for continual research to examine the physiology and anatomy of antibodies.

The report serves to identify prevailing growth trends based on which projections made. The report constitutes most relevant data pertaining to comprehend the growth dynamics of research antibodies market. Geographical distribution of the research antibodies market and an analysis of the competitive structure are highlights of the report.

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Global Research Antibodies Market: Key Trends

Currently, pharmaceutical and biopharmaceutical companies are undertaking extensive R&D activities to introduce novel products. These pursuits involve widespread use of antibodies because of their exceptional physiological properties. Therefore, research on antibodies receives a boost for their use in secondary cell research.

Pharmaceutical giants are also making hefty investments for advancement of antibodies research.

Increasing incidence of chronic diseases and life-threatening diseases such as cancer has led to extensive initiatives for advanced therapeutics. Pharmaceutical and biotechnology companies are making efforts in terms of upgrading their R&D capability and pumping money. These efforts are aimed to develop advanced therapeutics as well as personalized medicine for a gamut of chronic and fatal diseases. These factors collectively bode well for research antibodies market.

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At present, stem cell research is finding keen interest of researchers and geneticists. Several studies support the efficacy of stem cell for blood cancers, blood and bone marrow diseases, immune disorders. Lately, stem cells from the umbilical cord and stem cells from the blood stream have been used to treat rare blood related diseases. Due to the dependency an antibodies for stem cell research, researchers are involved to isolate different antibodies molecules. This is aiding growth of research antibodies market.

Lastly, novel use of antibodies that are receiving acceptance of accredited bodies is serving to boost the research antibodies market. For example, in a new development, FDA approved the clinical application of DNA-encoded monoclonal antibody therapy as a prevention against Zika virus.

Global Research Antibodies Market: Regional Analysis

The global research antibodies market is spread across North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa. Among them, North America holds supremacy in the overall market. The region being home to large biotechnology and biopharmaceutical companies, along with immense government aid for research are key factors behind exceptional growth of North America antibodies market.

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Stringent regulations in place for manufacturers of antibodies and due adherence to these regulations accounts for high quality products from the region. This further pushes the North America research antibodies market.

On the other hand, Asia Pacific is emerging as a key region for research antibodies. Increasing R&D for antibodies and adoption of novel techniques for the production of antibodies is serving to fuel the region.

Global Research Antibodies Market: Competitive Outlook

Prominent players in the global research antibodies market include Abcam plc, Agilent Technologies, and Thermo Fisher Scientific Inc.

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Research Antibodies Market is Driven by Increasing Incidence of Chronic Diseases and Life-threatening Diseases - Cheshire Media

Bone Marrow Stem Cells Comments Off on Research Antibodies Market is Driven by Increasing Incidence of Chronic Diseases and Life-threatening Diseases – Cheshire Media | November 30th, 2020

Medical skin care products are used for beautifying or to address some other skin care problems. The cosmetic industry is booming and skin care forms a very huge part of this industry. The aesthetic appearance is so important that people spend a lot on skin care products and treatment. People being more technologically aware of the various new skin care products trending in the market. In addition to the aesthetic application, the medical skin care products are also used to address issues such as acne, pimples or scars.

Medical Skin Care Products Market: Drivers and Restraints

The medical skin care products is primarily driven by the need of natural based active ingredients products which are now trending in the market. Consumers demand medical skin care products which favor health and environment. Moreover, the consumers are updated with the trends so that various companies end up providing such products to satisfy the customers. For instance, a single product face mask has thousands of different variants. This offers consumers different options to select the product depending on the skin type. Moreover, the market players catering to the medical skin care products are offering products with advanced technologies. For instance, Santinov launched the CICABEL mask using stem cell material based on advanced technologies. The stem cells used in the skin care product helps to to protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis.

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Medical Skin Care Products Market: Segmentation

On the basis of product type the medical skin care products market can be segmented as:

On the basis of application, the medical skin care products market can be segment as:

On the basis of distribution channel, the medical skin care products market can be segment as:

Medical Skin Care Products Market: Overview

Medical skin care products are used to address basic skin problems ranging from acne to scars. There are various advancements in the ingredients used to offer skin care products to the consumers. For instance, the use of hyaluronic acid and retinoids is the latest development in the industry. The anti-aging creams are at the forefront as the help treating issues such as wrinkles, scars, acne, and sun damage. Another, product in demand is the probiotic skincare which include lactobacillus and bifidobacterium.

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Medical Skin Care Products Market: Region-wise Outlook

In terms of geography, medical skin care products market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America dominated the global medical skin care products market as international players are acquiring domestic companies to make their hold strong in the U.S. LOral is accelerating its U.S. market by signing a definitive agreement with Valeant Pharmaceuticals International Inc. to acquire CeraVe, AcneFree and Ambi skin-care brands for US$ 1.3 billion. The acquisition is expected LOreal to get hold of the brands in the price-accessible segment. Asia Pacific is expected to be the fastest growing region owing to the increasing disposable income and rising awareness towards the skin care products.

Medical Skin Care Products Market: Key Market Participants

Some of the medical skin care products market participants are Avon Products Inc., Beiersdorf AG, Colgate-Palmolive Company, Kao Corporation, LOral S.A., Procter & Gamble, Shiseido Company, The Estee Lauder Companies Inc., Unilever PLC, Revlon, Clinique Laboratories, llc., Murad, LLC., SkinCeuticals, RMS Beauty, J.R. Watkins and 100% PURE.

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The end-use Industries to Help the Medical Skin Care Products Market stand in a good stead between 2017 and 2025 - Cheshire Media

Skin Stem Cells Comments Off on The end-use Industries to Help the Medical Skin Care Products Market stand in a good stead between 2017 and 2025 – Cheshire Media | November 30th, 2020

By Mark Philips.

New York - November 30th, 2020 - To put it simply, it concerns nanotechnological research, its adaptation and then application in cosmetology. Nanoasia, under the management of Kira Sorokina, was one of the first international companies to work in this field when it started more than five years ago. Nanoasia is a brand of exclusive cosmetics for use in salons and at home, which was the first to test and bring airbrush non-injection anti-ageing products to the market.

The secret lies in tiny nano particles, each around 4 nanometers in length (and so therefore smaller than the diameter of even the driest skin pores). This means that the active components can penetrate deeper into the skin without needing to use an injection, mentioned Kira Sorokina. The product contains peptides, biosynthesized from plants, amino acids (proteins) and plant extracts of the highest quality. It is important to note that Nanoasias ingredients are all able to serve their complex individual function due to the balanced recipe, which ensures that every ingredient compliments and enhances the others. This is why just a handful of components can come together to provide an integrated product that solves all of the most common issues, she added. Despite Nanoasia being produced in South Korea, using their technologies, all of the formulas are adapted to the needs of European skin types. The device and cosmetic products, developed and produced by Nanoasia, are designed to work with the skin, skin cells and facial muscles.

Now lets take a closer look at Nanoasias innovative components and how they work!

Nanoasias serums (which are currently produced in three distinct varieties) represent the new generation of non-injection bio-revitalizers. These unique plant-based nanocomplexes contain a high concentration of nano-peptides, amino acids and plant extracts. They target all of a skins age-related changes, penetrating directly into the dermis and working instantly from the first application! They can correct the faces oval shape, tightening the cheeks and restoring their elasticity. They iron out any smile lines and baggy skin under the eyes, whilst also helping lose any facial fat (by improving blood circulation and lymphatic drainage). They nourish and rejuvenate the skin at a cellular level. They help to lighten up any pigment stains and bleaching. They help to prevent muscular spasms, preserving your natural facial expressions, reducing puffiness and dark circles under the eyes. They restore the cellular structure of collagen fibers, preventing the sebaceous glands from becoming overactive. They enhance cell regeneration, removing any pigment stains and rebuilding the structure of the dermis.

Nanoasia has developed a unique device to allow these special serums to penetrate deep into the skin. Simply put, it is a portable compressor, suitable for use at a salon or, indeed, at home. Thanks to the products low-molecular composition and the tiny dimensions of the particles, non-injection mesotherapy using Nanoasias serums easily gets into the deeper layers of the skin, helped by the compressed air brush. The procedure of applying the product to the skin with a strong jet of air is as painless as can be.

Besides the serums, Nanoasia also produces many incredible products which work on both the dermis and the facial muscles. Our mousse, enzyme exfoliating roll and the serum effectively clean and maintain the skin thanks to their Air Bubbles technology. This is the ideal base care for everyone - deep and delicate cleansing, intense moisturization, nourishment and stimulation to help the skin become rejuvenated and regenerated. This all comes from the high concentration of peptides, amino acids and plant extracts.

The product containing nanoneedles (cream + serum) has a comprehensive effect: it lifts and rejuvenates the skin, eliminating wrinkles and pigmentation, improving skin tone and elasticity. It provides nutrition and protection to the skin, thanks to the inclusion of plant extracts, amino acids and the self-soluble nanoneedles (compounds derived from seaweed which ensure that the nutritional components can penetrate as far as possible into the skin).

Nanoasias creams have a unique formula. The My Che duet (cream for the skin around your eyes and face), our EVA body cream and VS - our air-cushioning cream - are all the first of their kind in the world. They contain a high concentration of amino acids (the building blocks of our very organisms), peptides and plant stem cell extracts from a 100 year old ginseng plant and a 1000 year old yew tree. The formulas of these products guarantee rejuvenation, recovery and care from within, at a cellular level, giving you a powerful lifting effect, nourishment, protection and ironing out any wrinkles, pigments and much more. Air Cushion is also SPF 50+ and contains UV protection thanks to its intelligent fluid formula and nano-particle technologies. This ensures the ideal coverage for every day, without clogging or overwhelming the pores. It is a light foundation with an almost weightless texture and is compatible with any skin color when heated.

Their products pay special attention to your facial muscles. Their mask contains 45 active components including peptides, extracts from gem stones and plants. The mask stimulates isometric pressures within the skin. The muscles pulsate against this pressure with the uniform pressure acting like yoga for the face. The muscles then become toned and stronger. Facial and dermal muscles are smoothed out, skin elasticity is restored, the youthful oval shape of one's face returns and double chins are removed. Our Nanolifting system for Youthful Skin is a revolutionary lifting mask forone's facial muscles and dermis, containing powerful antioxidant and antiseptic components. The mask contains the highly-prized components of Astragalus root extract, Trehalose, 9 different peptides and 12 plant extracts which combine to achieve the following: they slow down the ageing process of cells; kickstart the extracellular matrix; regulate the tension of the vascular wall (Rosacea) and stimulate the restoration of the structural elements of the dermis - collagen, elastin, fibronectin and glycosaminoglycans.

Besides its exterior care potential, Nanoasia also looks after the skin from within. To achieve this they have developed unique products, including a bio-active additive (Nanodessert Nutritional) and a youthful elixir (Nanocell Youth Elixir).

Nanoasia holds three patents for cutting-edge research in cosmetology, as well as having a few further patents pending approval. The company has not only won praise in Russia, CIS countries and Europe, but also made it to Canada and Panama, and it is expected to open a branch in the United States soon expressed Kira; today, Nanoasia has 60 representatives in 28 cities and 8 countries. Our brands mission is to give every woman the opportunity to hold onto her natural beauty for as long as possible.

Media ContactCompany Name: Prysma MediaContact Person: Mark PhilippsEmail: Send EmailCountry: United StatesWebsite: https://nanoasia.ru/

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What exactly is the revolutionary Smart Beauty Technology, and how Kira Sorokina, the Founder of NanoAsia leads it - Press Release - Digital Journal

Skin Stem Cells Comments Off on What exactly is the revolutionary Smart Beauty Technology, and how Kira Sorokina, the Founder of NanoAsia leads it – Press Release – Digital Journal | November 30th, 2020

The researchers noted a weakening of possible repair mechanisms of blood vessels in patients who showed clinically significant vasoplegia

Vasoplegia, where vaso refers to blood vessels and plegia stands for paralysis, is a condition where the patient exhibits a low blood pressure, even in the presence of normal or increased output of blood from the heart. When this occurs as a complication of cardiopulmonary bypass surgery, there is a chance that it can lead to multiple organ failure and even death. Now, a diverse group of researchers including clinicians, computational biologists and biotechnologists have come together to study how this may be predicted early on based on clinical observations, so that effective treatment may be given.

Also Read | Mumbais first robot-assisted cardiac surgery

In a pilot study involving 19 patients who underwent elective cardiac surgery, the researchers measured the circulating counts of endothelial progenitor cells and hematopoietic stem cells at different points in time starting from when the patient was being anaesthetised to until 24 hours after the surgery. They find that in a statistically significant number of people in the group that showed clinically significant vasoplegia, there was a blunting of the endothelial progenitor cell response. Also, in the group that did not show clinically significant vasoplegia, they observed that there was no such blunting.

We can say there appears to be a pattern, which is well worth exploring in a larger cohort of patients and further delineating this particular response as a biomarker in predicting a potentially devastating complication following cardiac surgeries, says Dr. Paul Ramesh Thangaraj, from the department of cardiothoracic surgery, Apollo Hospitals, Chennai, who is one of the PIs of the study. This research is published in the journal PLOS ONE.

Hematopoietic and endothelial progenitor cells play an important role in repair of damaged tissues and inner lining of the blood vessels called the endothelium, respectively. Usually, these cells reside in the bone marrow; however, in response to injury to a tissue or a blood vessel, they come out into the circulation from the bone marrow and home into the site of injury for tissue repair, says Madhulika Dixit from the Department of Biotechnology, Indian Institute of Technology Madras, in an email to The Hindu.

Prof Dixit describes using flow cytometry to measure the counts during the surgery and afterwards. The cells were identified by means of expression of specialised cell surface receptors. For this, at regular intervals the blood withdrawn from the patient was subjected to flow cytometry. We checked for time-dependent changes in circulating counts of progenitor cells during the course of cardiopulmonary bypass in patients.

Also Read | Minimally invasive cardiac surgery the best bet

One of the key challenges was to get significant patterns in this small dataset, according to Rahul Siddharthan, from The Institute of Mathematical Sciences, Chennai, who was one of the people involved in formal analysis. In this case, we have two data sets, with two-valued outcomes [non-vasoplegic or vasoplegic], and the goal is to see how other measured parameters can predict them, he says. There are very sophisticated machine-learning algorithms available these days for such tasks. In this case the most basic algorithm, logistic regression, is good enough, says Prof. Siddharthan.

As he explains, in both cases, the idea is to look at a single value (change in circulating progenitor cells at two timepoints) and in seeing its predictive power for the output. The trend is clear, that for non-vasoplegic patients, the level of circulating progenitor cells increases, while for vasoplegic patients, it stays flat or decreases. There are exceptions but the finding is statistically significant even on this small study, says Prof. Siddharthan.

With a larger study, Dr.. Paul Ramesh envisages even developing a risk score for predicting vasoplegia as a complication following surgery.

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Pilot study finds potential signal indicative of loss of tone in blood vessels after cardiac surgery - The Hindu

Cardiac Stem Cells Comments Off on Pilot study finds potential signal indicative of loss of tone in blood vessels after cardiac surgery – The Hindu | November 30th, 2020

Myocardial Infarction Drug used to treat Heart Attack. Medicines and chemical substances that can cause myocardial infarction. Treatment ranges from lifestyle changes and cardiac rehabilitation to medication, stents, and bypass surgery.

Myocardial Infarction Drug Market is anticipated to grow at a CAGR of +6% during the forecast period 2020-2028.

A Global Myocardial Infarction Drug Market analysis and forecast is released based on a wide study of the market. Statistics about the approaching market trends as well as the current scenario of the market is a vital implement for existence and development in the constantly developing industry.

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Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Myocardial Infarction Drug Market which would mention How the Covid-19 is affecting the Myocardial Infarction Drug Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Myocardial Infarction Drug Players to Combat Covid-19 Impact.

The Top Key Players of the global Myocardial Infarction Drug Market:

BioCardia, Inc., Laboratoires Pierre Fabre SA, Human Stem Cells Institute, CSL Limited, Capricor Therapeutics, Inc., Hemostemix Ltd, Compugen Ltd., Celyad SA, FibroGen, Inc., Lees Pharmaceutical Holdings Limited, Juventas Therapeutics, Inc., Cynata Therapeutics Limited, CellProthera, Biscayne Pharmaceuticals, Inc., HUYA Bioscience International, LLC, LegoChem Biosciences, Inc, Immune Pharmaceuticals Inc.

Segmentation by Product type:

Segmentation by Application:

Market Segmentation by Region:

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The Global Myocardial Infarction Drug Market has demonstrated an increasing need to alter the policies that are being currently used by the players so as to exhibit commercial capacities of the manufacturers, distributors, and vendors. This helps the key players in developing a firm strategy that is flexible enough to keep up with future events in the market space.

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Global Myocardial Infarction Drug Market to have sustainable growth over the forecast period 2020-2028| Leading Players BioCardia, Inc., Laboratoires...

Cardiac Stem Cells Comments Off on Global Myocardial Infarction Drug Market to have sustainable growth over the forecast period 2020-2028| Leading Players BioCardia, Inc., Laboratoires… | November 30th, 2020

The U.S. Food and Drug Administration (FDA) has approved naxitamab* (naxitamab-gqgk; Danyelza; Y-mAbs Therapeutics), a humanized form of the mouse antibody 3F8, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response (PR), minor response (mR), or stable disease (SD) to prior therapy.[1]

A rare diseaseNeuroblastoma is a heterogeneous pediatric neoplasm that arises in the sympathetic nervous system. The disease is the most common extra-cranial solid tumor in infants and children, representing between 8%-10% of all childhood tumors. Overall, neuroblastoma accounts for approximately 15% of all cancer-related deaths in children. [1]

The clinical behavior of neuroblastoma is highly variable, with some tumors being easily treatable, resulting in near-uniform survival. The majority of tumors are, however, very aggressive, with a high risk of death. [2] Age, stage, and amplification of the MYCN oncogene are the most validated prognostic markers.[2]

The incidence of neuroblastoma is 10.2 cases per million children under 15 years of age. [3] In the United States, nearly 700 new cases are reported each year. While 90% of cases are diagnosed before the age of 5, approximately 30% of patients are diagnosed within the first year. The median age of diagnosis is 22 months. [4]

Neuroblastoma develops in very early forms of nerve cells that are usually found in a developing baby, which explains why children as young as newborns can develop this cancer.

The disease rarely presents in adolescence and adulthood, but outcomes are much poorer in this age group. There does not appear to be an increased prevalence among races, but there is a slight predilection for males (1.2:1).[4]

Neuroblastoma develops in a part of the peripheral nervous system called the sympathetic nervous system. Since some of the sympathetic nervous system cells are concentrated in the adrenal glands, which sit above the kidneys, neuroblastoma often starts growing there. Tumors typically begin in the belly, neck, chest, pelvis, or adrenal glands and can spread to other parts of the body, including the bones.

All patients are staged based on the International Neuroblastoma Staging System Committee (INSS) system, ranging from stage 1 through stage 4S. Based on this staging system, patients with stage 4 disease diagnosed after one year of age are classified in the high-risk category, where the neuroblastoma tumor cells have already metastasized to other sites in the body, such as the bone or bone marrow.

Essentially all patients who have tumors with many copies, or amplification, of the MYCN oncogene also have high-risk disease, even if they do not have evidence of the tumor having spread.

Although children with a family history of neuroblastoma may have a higher risk for developing this disease, this factor accounts for only 1-2 % of all cases of neuroblastoma. The vast majority of children who develop the tumor, do not have a family history of the same.

Mechanism of actionIn simple terms, naxitamab, conceived and developed by physician-scientist Nai-Kong Cheung, M.D., Ph.D., a medical oncologist at Memorial Sloan Kettering ** who heads the organizations neuroblastoma program, detects neuroblastoma cells that have survived chemo- or radiation therapy by attaching to GD2, a ganglioside that is ubiquitously expressed in the plasma membrane of neuroblastoma and is shed into the circulation, after which the patients own immune system, especially white blood cells, can destroy the malignant neuroblastoma cells. [5]

In the late 1980s, investigators at Memorial Sloan Kettering started using 3F8 in combination with surgery and chemotherapy to treat patients diagnosed with neuroblastoma. The investigational treatment significantly improved cure rates for pediatric patients with high-risk disease.

Later, in 2007, Cheung and colleagues began developing a humanized form of 3F8 called Hu3F8. In August 2011 the researchers started a phase I study of Hu3F8 (NCT01419834). The study was designed to investigate the best and safest dose to give to patients.

Accelerated approval The new indication of naxitamab + GM-CSF is approved under accelerated approval regulation based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial.

Naxitamab is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. The drug is administered to patients three times per week in an outpatient setting and the treatment is repeated every four weeks. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA.

Much needed treatmentOver the last decades, the development of novel treatments for pediatric cancers has been successful. For example, the five-year survival rates for children diagnosed with cancer in the late 1980s approaches 70%. For some types of localized embryonal tumors, including retinoblastoma and Wilms tumor, the cure rates approach or exceed 90%.

However, for every two children who survive today, one child still succumbs to their disease. And for some childhood cancers, such as neuroblastoma and certain types of brain cancer, the prognosis remains poor. Hence, despite the observed successes, there remained a major unmet medical need remains patients diagnosed with neuroblastoma. The development and subsequent approval of naxitamab may be one much-needed treatment options for these patients. [6]

[The approval represents a major milestone] for children living with refractory/relapsed high-risk neuroblastoma, noted Thomas Gad, founder, Chairman, and President of Y-mAbs Therapeutics, whose own daughters neuroblastoma was successfully treated with 3F8 at Memorial Sloan Kettering more than a decade ago.

In 2015, Memorial Sloan Kettering licensed Hu3F8 to Y-mAbs Therapeutics tpo expand the clinical trial and development program and manufacturing of naxitamab.

Its very exciting to see this treatment go from being an experimental therapy used at my daughters bedside to now being FDA approved, Gad added.

We believe that naxitamab in combination with GM-CSF is a much-needed treatment for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have historically not had approved treatments available. This approval of Y-mAbs first BLA represents a key step in working towards our mission of becoming a world leader in developing better and safer antibody-based oncology products addressing unmet pediatric and adult medical needs, said Claus Moller, Y-mAbs Therapeutics Chief Executive Officer.

Clinical trialsThe FDA approval of naxitamab is supported by clinical evidence from two pivotal studies in patients with high-risk neuroblastoma with refractory or relapsed disease.

In these clinical studies, naxitamab appears to be well tolerated with few discontinuations of treatment. The observed treatment-related adverse events were clinically manageable.

The efficacy of naxitamab in combination with GM-CSF was evaluated in two open-label, single-arm trials in patients with high-risk neuroblastoma with refractory or relapsed disease in the bone or bone marrow.

Both trials included patients with relapsed or refractory neuroblastoma in the bone marrow or bone. Participating patients received a 3 mg/kg of naxitamab intravenously on days one, three, and five of each four-week cycle, in addition to GM-CSF subcutaneously, or under the skin, at varying doses throughout the cycle. Patients were allowed to receive preplanned radiation in specific areas based on which trial they were enrolled in.

Efficacy outcomes included overall response rate (ORR) according to the revised International Neuroblastoma Response Criteria (INRC), as determined by independent pathology and imaging review and confirmed by at least one subsequent assessment. An additional efficacy outcome measure was the duration of response (DOR).

Study 201In the first study (Study 201; NCT03363373), a multicenter open-label, single-arm trial. researchers evaluated the combination of naxitamab in combination with GM-CSF in a subpopulation of patients who had refractory or relapsed high-risk neuroblastoma in the bone or bone marrow and demonstrated a partial response, minor response, or stable disease to prior therapy. Patients with progressive disease were excluded.

Of the 22 patients included in the efficacy analysis, 64% had refractory disease and 36% had relapsed disease. The median age was 5 years (range 3 to 10 years), 59% were male; 45% were White, 50% were Asian and 5% were Black.

MYCN amplification was present in 14% of patients and 86% of patients were International Neuroblastoma Staging System (INSS) stage 4 at the time of diagnosis. Disease sites included 59% in the bone only, 9% in bone marrow only, and 32% in both. Prior therapies included surgery (91%), chemotherapy (95%), radiation (36%), autologous stem cell transplant (ASCT) (18%), and anti-GD2 antibody treatment (18%).

Study 12-230The second study (Study 12-230; NCT01757626), a single-center, open-label, single-arm clinical trial, included a subpopulation of patients who had relapsed or refractory high-risk neuroblastoma in bone or bone marrow and demonstrated a partial response, minor response, or stable disease to prior therapy. In this study patients with progressive disease were excluded.

Participating patients received at least one systemic therapy to treat disease outside of the bone or bone marrow prior to enrollment. They were required to have received at least one dose of naxitamab at a dose of 3 mg/kg or greater per infusion and have evaluable disease at baseline according to independent review per the revised INRC. Radiation to non-target bony lesions and soft tissue lesions was permitted at the investigators discretion (assessment of response excluded sites that received radiation).

Of the 38 patients included in the efficacy analysis, 55% had relapsed neuroblastoma and 45% had refractory disease; 50% were male, the median age was 5 years (range 2 to 23 years), 74% were White, 8% Asian and 5% were Black, 5% Native American/American Indian/Alaska Native, 3% other races and 5% was not available. MYCN-amplification was present in 16% of patients and most patients were International Neuroblastoma Staging System (INSS) stage 4 (95%).

Fifty percent (50%) of patients had disease involvement in the bone only, 11% only in bone marrow, and 39% in both. Prior therapies included surgery (100%), chemotherapy (100%), radiation (47%), autologous stem cell transplant (ASCT) (42%), and anti-GD2 antibody treatment (58%)

Adverse eventsThe most common adverse reactions (incidence 25% in either trial) in patients receiving naxitamab were infusion-related reactions, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability.

The most common Grade 3 or 4 laboratory abnormalities (5% in either trial) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased alanine aminotransferase, decreased glucose, decreased calcium, decreased albumin, decreased sodium, and decreased phosphate.

Boxed warningThe prescribing information for naxitamab contains a Boxed Warning which states that the drug can cause serious infusion-related reactions and neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Hence, to mitigate these risks, patients should receive premedication prior to each naxitamab infusion and be closely monitored during and for at least two hours following completion of each infusion.

Note* Also known as humanized 3F8 or Hu3F8,** Researchers at Memorial Sloan Kettering Cancer Center (MSK) developed naxitamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and Y-mAbs.

Clinical trialsHumanized 3F8 Monoclonal Antibody (Hu3F8) in Patients With High-Risk Neuroblastoma and GD2-Positive Tumors NCT01419834Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors NCT01662804Humanized Anti-GD2 Antibody Hu3F8 and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma NCT02650648Study of the Safety and Efficacy of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma and Other Solid Tumor Cancers NCT03860207Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma NCT01757626Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow NCT03363373

Highlights of prescription informationNaxitamab (naxitamab-gqgk; Danyelza; Y-mAbs Therapeutics) [Prescribing Information]

Reference[1] Park JR, Eggert A, Caron H. Neuroblastoma: biology, prognosis, and treatment. Hematol Oncol Clin North Am. 2010 Feb;24(1):65-86. doi: 10.1016/j.hoc.2009.11.011. PMID: 20113896.[2] Modak S, Cheung NK. Neuroblastoma: Therapeutic strategies for a clinical enigma. Cancer Treat Rev. 2010 Jun;36(4):307-17. doi: 10.1016/j.ctrv.2010.02.006. Epub 2010 Mar 12. PMID: 20227189.[3] Maris JM. Recent advances in neuroblastoma. N Engl J Med. 2010 Jun 10;362(23):2202-11. doi: 10.1056/NEJMra0804577. PMID: 20558371; PMCID: PMC3306838.[4] Esiashvili N, Anderson C, Katzenstein HM. Neuroblastoma. Curr Probl Cancer. 2009 Nov-Dec;33(6):333-60. doi: 10.1016/j.currproblcancer.2009.12.001. PMID: 20172369.[5] Balis FM, Busch CM, Desai AV, Hibbitts E, Naranjo A, Bagatell R, Irwin M, Fox E. The ganglioside GD2 as a circulating tumor biomarker for neuroblastoma. Pediatr Blood Cancer. 2020 Jan;67(1):e28031. doi: 10.1002/pbc.28031. Epub 2019 Oct 14. PMID: 31612589.[6] Balis FM. The Challenge of Developing New Therapies for Childhood Cancers. Oncologist. 1997;2(1):I-II. PMID: 10388032.

Featured image: A close up of a newborn babys foot in the neonatal unit in a hospital. Photo courtesy: 2016 2020 Fotolia/Adobe. Used with permission

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US FDA Approves Naxitamab for the Treatment of Neuroblastoma - OncoZine

Bone Marrow Stem Cells Comments Off on US FDA Approves Naxitamab for the Treatment of Neuroblastoma – OncoZine | November 28th, 2020

Since the discovery of induced pluripotent stem cells (iPSCs) in 2006, a large and thriving research products market has emerged, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment, because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number.

Therapeutic applications of iPSCs are also emerging. In 2013, RIKEN launched the worlds first study of an iPSC-derived cell therapy product, treating the first patient in 2014 with iPS cell-derived retinal sheets.Numerous studies with iPSCs have also been undertaken in Japan, with iPSC-derived treatments being used for the treatment of Parkinsons disease, heart disease, spinal cord injury, and platelet production.

In a world-first achieved in 2016, Cynata Therapeutics received approval to launch the worlds first formal trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate.

While the therapeutic progress is exciting, other methods of commercializing iPS cells have also expanded exponentially.

Since the discovery of iPSC technology nearly 15 years ago, exponential progress has been made in stem cell biology and regenerative medicine.

New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated.

What do you think the next 15 years will hold? Let us know in the comments below.

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Induced Pluripotent Stem Cell (iPS Cell) Applications in 2020

IPS Cell Therapy Comments Off on Induced Pluripotent Stem Cell (iPS Cell) Applications in 2020 | November 28th, 2020

Introduction

An increasing number of patients with end-stage renal failure are undergoing dialysis therapy worldwide. It causes both medical and medicoeconomic problems. Renal transplantation has proven a successful therapy for most patients with end-stage renal failure, as the therapy results in a significant improvement in the patients quality of life, prolongs survival and is considered cost-effective [1]. However, the annual increase in the number of new patients with end-stage renal disease who need a renal transplant, and the widening gap between the demand for and the supply of donor kidneys have led to a progressive shortage of donor organs for transplant. This has become a serious issue and is worsened by the problem of limited graft survival due to immune rejection [1].

Among the strategies to overcome these problems is kidney regeneration using stem cells. Stem cells may be divided into two large categories: organ-specific or somatic stem cells and pluripotent stem cells. In contrast to organ-specific stem cells that generally have a limited potential for growth and differentiation, pluripotent stem cells, such as embryonic stem cells (ESCs) [24] and induced pluripotent stem (iPS) cells [57], have a virtually unlimited replicative capacity on culture dishes and are theoretically able to give rise to any cell type in the body. Stem cells have increasingly been used as a model system for understanding developmental mechanisms. In addition, in vitro culture and differentiation of stem cells offer unique opportunities for disease modeling, drug discovery, toxicology and cell replacement therapy [8]. The generation of specific functional cell types from ESCs has been demonstrated, including neural cells (several kinds of neuron and glia), vascular endothelia and smooth muscle, cardiomyocytes, hematopoietic cells, pancreatic insulin-producing cells and hepatocyte-like cells [8]. However, the protocol for in vitro differentiation of pluripotent stem cells into renal lineage cells has not been fully established.

Other approaches to regenerate kidney have also been investigated using organ-specific local stem cells within the kidney and bone marrow-derived hematopoietic stem cells [9]. Kidney regeneration using mesenchymal stem cells localized in bone marrow has also been examined [10]. However, the approaches are still being developed and the role of these stem cells in kidney regeneration remains to be well defined.

Therapeutic approaches using human ESCs face two major problems. One is the ethical issue derived from the use of human fertilized eggs, and the other is immune rejection in any cell or tissue transplantation due to histocompatibility antigenic differences between ESCs and patients. These problems have been overcome by a breakthrough experiment by Takahashi and Yamanaka. They identified four factors normally found in ESCs, Oct3/4, Sox2, c-Myc and Klf4, that were sufficient to reprogram both mouse and human somatic cells to closely resemble mouse and human ESCs [57]. They named these iPS cells. Since iPS cells can be generated from somatic cells of patients, clinical approaches using iPS cells are not associated with the two above problems (use of human fertilized egg and immune rejection). In the next natural step after iPS cell creation, significant progress has been made in redifferentiating iPS cells into somatic cells. As is the case with ESCs, iPS cells have been redifferentiated into several somatic tissues, including active motor neurons [11], insulin-secreting islet-like clusters [12], hepatocyte-like cells [13,14] and a number of cardiovascular cells (arterial endothelium, venous endothelium, lymphatic endothelium, cardiomyocytes), but not kidney [15,16].

This chapter first summarizes the mechanisms of kidney development and the research on the directed differentiation of ESCs into renal lineages based on the knowledge of kidney development. In vitro generation of kidney using the undifferentiated cell mass in amphibian eggs, similar to mammalian pluripotent stem cells in that the cell mass can differentiate into various organs in vitro, is also described as a reference to kidney regeneration in mammals. Recent advances in the iPS cell research and technology are then reviewed, and finally the future direction of iPS cells in the field of regenerative nephrology is described.

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Induced Pluripotent Stem Cell - an overview ...

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Stem cell-derived cells are ready-made human induced pluripotent stem cells (iPS) and iPS-derived cell lines that are extracted ethically and have been characterized as per highest industry standards. Stem cell-derived cells iPS cells are derived from the skin fibroblasts from variety of healthy human donors of varying age and gender. These stem cell-derived cells are then commercialized for use with the consent obtained from cell donors. These stem cell-derived cells are then developed using a complete culture system that is an easy-to-use system used for defined iPS-derived cell expansion. Majority of the key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

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The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

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North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

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The Stem Cell-Derived Cells market to Scale new heights in the next decade - Khabar South Asia

IPS Cell Therapy Comments Off on The Stem Cell-Derived Cells market to Scale new heights in the next decade – Khabar South Asia | November 28th, 2020

Share This Article:A stem cell research center at UC Davis. Courtesy California Institute for Regenerative MedicineBy Barbara Feder Ostrov | CalMatters

Californias stem cell research agency was supposed to be winding down its operations right about now, after a 16-year run and hundreds of millions in grants to scientists researching cutting-edge treatments for diabetes, cancer, Alzheimers and other diseases.

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Instead, the taxpayer-supported California Institute for Regenerative Medicine will get a $5.5 billion reboot after voters earlier this month narrowly passed the Proposition 14bond measure. The overall cost of the bonds with interest will total about $7.8 billion.

Were thrilled that California voters saw fit to continue the work weve done, said Jonathan Thomas, chair of the agencys governing board. California has always had a frontier mentality and a love for the cutting edge, and the work that CIRM has done has put it on the very forefront of regenerative medicine.

Even with Californias economy in a coronavirus-induced tailspin and somescientists arguingthat stem cell research no longer needs taxpayer support,Prop. 14passed with 51 percent of the vote after well-financed supporters pourednearly $21 millioninto the Yes on 14 campaign. The measure was essentially a rerun of Proposition 71, which California voters approved in 2004 after a since-revoked federal ban on embryonic stem cell research.

The cash infusion is expected to keep the institute running for another 10 to 15 years, although the agency will see some significant changes under Prop. 14.

The institute also must contend with longstanding concerns over conflicts of interest that have dogged it since its inception, observers say. About 80% of the money distributed has gone to universities and companies tied to agency board members, according to an analysisby longtime agency watchdog David Jensen, a former Sacramento Bee journalist who runs theCalifornia Stem Cell Reportblog and wrote abookon the institute.

Prop. 14 allows the agency to fund a wider array of research projects even some that dont involve stem cells, but instead are related to genetics, personalized medicine and aging.

Thats necessary because the field has evolved, said Paul Knoepfler, a UC Davis professor of cell biology who studies the role of stem cells in cancer and writes a stem cell blog. He received a 2009 grant from the institute.

Stem cells are interesting and important, but there are going to be a lot of new therapies in the next 10 years that are not stem-cell centric, Knoepfler said.

Other changes for the agency include:

Ysabel Duron, who joined the institutes board late last year, said she sees her role as promoting equity in opportunities for both researchers and patients and ensuring that treatments resulting from the research can benefit all Californians.

Researchers in particular need to boost the diversity of patients in their clinical trials and do a better job communicating the value of their work to the public, Duron said, noting that nearly 40% of Californians are Latino.

We need to keep researchers feet to the fire, said Duron, a former television journalist and founder of the Latino Cancer Institute. They need to show us a plan and we need to reward them.

To date, the agency has funded 64 clinical trials of treatments for many types of cancer, sickle cell disease, spinal cord injuries, diabetes, kidney disease and amyotrophic lateral sclerosis, commonlyknown as Lou Gehrigs disease.But the most advanced trials involve therapies for relatively rare conditions, such asSevere Combined Immunodeficiency known as the bubble baby disease, Jensen noted. That therapy is being reviewed by the FDA but has not yet been approved.

Cancer, heart disease these are the big killers. Thats what most people are interested in, Jensen said. You can fund something for a rare disease, but that doesnt affect the majority of Californians.

And, Jensen asks, what will happen after the agency runs out of money again? Will taxpayers once again be asked to refill its coffers? There was hope when the agency began that revenues from successful treatments would sustain its grant-making in the years to come, but the institute has only received a few hundred thousand dollars, not nearly enough to become self-sustaining without taxpayer support, according to theLegislative Analysts Office.

The sustainability issue is important and its hard to address, Jensen said. The money doesnt last forever.

Stem Cell Medical Research to Expand in California Following Passage of Prop. 14 was last modified: November 27th, 2020 by Editor

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Stem Cell Medical Research to Expand in California Following Passage of Prop. 14 - Times of San Diego

Spinal Cord Stem Cells Comments Off on Stem Cell Medical Research to Expand in California Following Passage of Prop. 14 – Times of San Diego | November 28th, 2020

SHANGHAI, China, Nov. 27, 2020 (GLOBE NEWSWIRE) -- ECMOHO Limited (Nasdaq: MOHO) (“ECMOHO” or the “Company”), a leading integrated solutions provider in the non-medical health and wellness market in China, today announced that it will release its unaudited financial results for the third quarter ended September 30, 2020 on Monday, November 30, 2020.

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ECMOHO to Announce Third Quarter 2020 Unaudited Financial Results

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Approval by MHLW provides new HIF-PH inhibitor treatment option for healthcare providers and adult patients with anemia of CKD not on dialysis Approval by MHLW provides new HIF-PH inhibitor treatment option for healthcare providers and adult patients with anemia of CKD not on dialysis

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Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis

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Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE™ (setmelanotide) as First-ever Therapy for Chronic Weight Management in Patients with...

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CAMBRIDGE, Mass., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced that they have executed a global collaboration and license agreement to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder (MDD), postpartum depression (PPD) and other psychiatric disorders and SAGE-324 for essential tremor and other neurological disorders.

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Biogen and Sage Therapeutics Announce Global Collaboration to Develop and Commercialize Potential Breakthrough Therapies in Depression and Movement...

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SAN DIEGO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- SmartPharm Therapeutics, Inc. (“SmartPharm”), a wholly-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), and developer of next-generation, non-viral gene therapy technologies, announced today that it has been awarded a contract from the Defense Advanced Research Projects Agency (DARPA) co-funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop a rapid countermeasure to COVID-19. The contract would provide SmartPharm up to USD $34 million for development through Phase 2 clinical studies of a gene-encoded antibody (“Gene MAb”) that could enable rapid protection from and/or treatment of SARS-CoV-2 infection and COVID-19. Sorrento will seek further funding in support of the COVID Gene MAb program toward EUA (emergency use authorization) approval and large-scale manufacturing pending successful clinical studies.

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DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded...

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FLORHAM PARK, N.J., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that members of the management team will participate at two upcoming virtual investor conferences in December, including:

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Phathom Pharmaceuticals to Participate at Upcoming Investor Healthcare Conferences

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TORONTO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly owned subsidiary Dialco Medical Inc. (“Dialco”), today announced the details for the Company’s upcoming Virtual Investor Day, scheduled to be held on Friday, December 4, 2020 at 10:00 a.m. EST.

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Spectral Medical to Host Virtual Investor Day on December 4, 2020

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MALVERN, Pa., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases, today announced Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen, will speak on “The Promise of Cell & Gene Therapies: Regulatory and Reimbursement Roadblocks” at Xconomy’s Xcelerating Life Sciences New York & Philadelphia Virtual Event on December 3 at 10:30 a.m. This panel will be moderated by Theresa Lavoie, Principal, Fish & Richardson and also feature panelists, Greg White, Senior Director, Global Market Access Policy – Janssen, Pharmaceutical Companies and Snehal Naik, Global Regulatory Affair- Advanced Therapies, Janssen R&D.

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CEO Dr. Shankar Musunuri to be Featured as a Panelist at Xconomy’s Xcelerating Life Sciences Virtual Event Discussing The Promise of Cell & Gene...

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Future References to Lead Drug Candidate for Alzheimer’s Disease Will Be Simufilam Future References to Lead Drug Candidate for Alzheimer’s Disease Will Be Simufilam

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USAN Modifies Lead Drug Candidate’s Chemical Name to ‘Simufilam’

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– R&D activities focused on advancing the development of innovative delivery systems and yeast beta glucan as a potential inhalable therapeutic for COVID-19 –

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Ceapro Inc. Reports 2020 Third Quarter and Nine-Month Financial Results and Operational Highlights

Global News Feed Comments Off on Ceapro Inc. Reports 2020 Third Quarter and Nine-Month Financial Results and Operational Highlights | November 28th, 2020